In recent years, there has been a notable increase in the number of therapeutic molecules. This increase has led to a corresponding increase in the number of CDMOs like us. With so many CDMOs to choose from, it is crucial for biopharmaceutical companies to carefully consider their selection criteria.
Finding the Right Biologics CDMO Partner
To ensure that you select the right biologics CDMO partner for your project, it’s important to ask yourself:
- Will you be working with the CDMO throughout the entire drug development process, from discovery to commercialization?
- At what point will your collaboration with the CDMO for commercial manufacturing begin – during preclinical or clinical development?
Once you have answered these questions, there are four key criteria to consider to select your perfect CDMO partner:
1. Your Drug Development Stage
This is a crucial deciding factor in determining whether to outsource or keep it in-house. The stage of your drug development will also impact the amount of material needed, potentially influencing your choice of CDMO based on their capacity and facility space to produce the required quantity. Additionally, an experienced CDMO can help you gain a better understanding of the timeline achievable for cGMP manufacturing and clinical trial initiation based on various factors.
53Biologics has a cGMP facility for your preclinical and clinical batches or development needs.
2. Range of Services
Choosing to partner with a single CDMO for every phase of drug development is ideal, almost utopic. Using an all-in-one CDMO can have advantages such as improved communication and better timeline management with less risk for overlap when moving from one CDMO to another. But, in most cases, it is not be possible due to availability constraints and the flexibility needed to meet Phase I timelines.
It is also important to consider the costs associated with using more than one CDMO, including potential royalties for transferring from one CDMO to another. To minimize costs, it is essential to review the stages of development and identify which stages will remain in-house and which ones will be outsourced, and to which CDMO.
For most projects, 53Biologics can be your all-in-one CDMO. In the cases that is no feasible, 53Biologics has a strong network of partners and collaborators.
3. Transparency Regarding Costs
When you receive the final cost estimates from potential CDMOs, it’s important to ask whether their figures include projected out-of-pocket expenses and capitalized costs.
The cost of drug development can be highly unpredictable due to various factors, including discoveries made during early-stage development and results from clinical trials. Therefore, working with an experienced CDMO becomes even more crucial to keep costs under control.
53Biologics has demonstrated to be cost competitive due to the lean and flexible operations structure.
Work a checklist of questions to ask to the potential Biologics CDMO partner, including whether or not you need to pay royalties when the project transitions from one CDMO partner to another, re-work due to molecule failures in early-stage testing, etc.
4. Speed and Quality of Development and Production
To launch a new drug quickly and be the first on the market, it is crucial to work with an experienced CDMO. Their track record make them easier to identify potential issues during the process design phase using design of experiments (DoE) techniques, reduce risks and scale up drug development processes faster.
In addition, the CDMO facilities have to be equipped with the technologies and facilities needed for the development of specific drugs.
53Biologics equipment can be adapted to your project and we are ISO 9001, ISO 14001 and GMP certified
Conclusion
53Biologics is a biologics CDMO that specializes in the decoding of biologics production. We offer services such as cell banking, analytical development, process development and batch production under cGMP guidelines.
Our company prides itself on its speed, proactivity,and efficiency. We collaborate closely with drug sponsors to develop innovative solutions for complex drug delivery problems and create cutting-edge medicines.
53Biologics provide complete CDMO services. Contact us today to learn more.
